Acute PainPhase 4NCT05118399
Analgesic Effect of Liposomal Bupivacaine
A Phase 4 study testing Bupivacaine Injection [Marcaine] and Bupivacaine Liposome 13.3 MG/ML [Exparel] in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery, and is usually associated with moderate postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Bupivacaine Injection [Marcaine] and Bupivacaine Liposome 13.3 MG/ML [Exparel]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Nov 2021to 8 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist (ASA) status I-III
- Age 18-90 years old
- Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)
- Patients with informed consent to participate in the study
Who cannot join
- Ulnar shaft/ neck physis fracture
- Revision surgery
- Previous fractures or surgery in the affected distal radius
- Surgery involving more than the affected arm
- Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
- Cases with painful conditions affecting the upper limb prior to surgery such as cervical spine, shoulder, elbow, other hand and wrist problems
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- Cases with baseline (pre-injury) QuickDASH score worse than 10 out of 100
- Respiratory compromise (requires long term oxygen)
- History of seizures
- Pre-existing neurological disorder/deficit
- Chronic opioid user (use for 3 months or more)
- Presence of chronic pain condition (pain duration over 3 months)
- Alcohol or substance abuse
- Psychiatric illness
- Impaired mental state
- Local infection
- Allergy to analgesic drugs: local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids
- Impaired renal function (defined as effective glomerular filtration rate less than 30ml/min/1.73m2
- Impaired liver function (defined as plasma bilirubin over 34micromol/L; international normalized ratio [INR] 》／=1.7, alanine aminotransferase [ALT] over 100U/L, aspartate aminotransferase [AST] over 100U/L)
- Coagulopathy (platelet count 《100,000/ml and/or INR 》／=1.5) or the use of anticoagulants (not including aspirin) that precludes the use of supraclavicular BPB
- Pregnancy
- Patient refusal for regional nerve blocks
- Patient refusal to join the clinical trial
- Patient unable/unwilling to attend post-op rehabilitation programme
- Injury on duty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Liposomal Bupivacaine to Standard Bupivacaine Versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: a Randomized Controlled Trial
Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery, and is usually associated with moderate postoperative pain. Poor postoperative pain control can impair rehabilitation, delay recovery and negatively impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. Liposomal bupivacaine can provide longer analgesia for up to 72 hours, and may therefore achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics. A number of clinical trials have studied the effect liposomal bupivacaine given as local infiltration. However, there is little evidence on liposomal bupivacaine for regional nerve blocks, and the use of liposomal bupivacaine for supraclavicular brachial plexus block - which is used for regional anaesthesia for distal radial fracture surgery - have not been studied before. This project is a randomized controlled trial to determine whether adding liposomal bupivacaine to long-acting local anaesthetics for supraclavicular BPB will improve and prolong postoperative analgesia in patients undergoing distal radial fracture surgery. Longer term secondary outcomes would be accessed including upper limb functional scores, chronic pain, and health related quality of life.
- Conditions
- Acute Pain
- Being tested
- Bupivacaine Injection [Marcaine], Bupivacaine Liposome 13.3 MG/ML [Exparel]
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Injection [Marcaine]Drug
Bupivacaine injection [Marcaine] is the standard treatment used in our hospital.
Bupivacaine Liposome 13.3 MG/ML [Exparel]Drug
Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| To receive supraclavicular BPB using standard ropivacaine only. | Active comparator | 20ml of plain bupivacaine will be injected using 2 syringes, so 10ml of 0.5% plain bupivacaine will be injected, and immediately followed by another 10ml of 0.5% plain bupivacaine. Receives: Drug: Bupivacaine Injection [Marcaine] |
| To receive supraclavicular BPB using liposomal bupivacaine together with ropivacaine. | Experimental | 10ml of 0.5% plain bupivacaine will be injected, and immediately followed by 10ml of 1.33% liposomal bupivacaine. Receives: Drug: Bupivacaine Liposome 13.3 MG/ML [Exparel] |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative AUC pain score at rest
Pain severity would be rated at rest after surgery using numerical rating scale with 0 to 10 where 0=no pain and 10=the worst possible pain
Measured: First 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start15 Nov 2021
- Primary completion8 Dec 2022
- Study completion8 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Sau Ching Stanley, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118399
- Sponsor's protocol ID
- UW21-046
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Liposomal Bupivacaine to Standard Bupivacaine Versus Standard Bupivacaine Alone in the Supraclavicular Brachial Plexus Block: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05118399
- Acronym / sponsor ID
- UW21-046
- Conditions
- Acute Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Mar 2023 (actual)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Brachial plexus blocks (BPB) are commonly used to provide regional anaesthesia for patients undergoing distal radial fracture surgery. Distal radial (DR) fracture surgery is a commonly performed orthopaedic surgery, and is usually associated with moderate postoperative pain. Poor postoperative pain control can impair rehabilitation, delay recovery and negatively impact outcomes after surgery. Liposomal bupivacaine (EXPAREL) is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. Liposomal bupivacaine can provide longer analgesia for up to 72 hours, and may therefore achieve greater analgesic efficacy compared to non-liposomal long-acting local anaesthetics. A number of clinical trials have studied the effect liposomal bupivacaine given as local infiltration. However, there is little evidence on liposomal bupivacaine for regional nerve blocks, and the use of liposomal bupivacaine for supraclavicular brachial plexus block - which is used for regional anaesthesia for distal radial fracture surgery - have not been studied before. This project is a randomized controlled trial to determine whether adding liposomal bupivacaine to long-acting local anaesthetics for supraclavicular BPB will improve and prolong postoperative analgesia in patients undergoing distal radial fracture surgery. Longer term secondary outcomes would be accessed including upper limb functional scores, chronic pain, and health related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| To receive supraclavicular BPB using standard ropivacaine only. | Active comparator | Drug: Bupivacaine Injection [Marcaine]20ml of plain bupivacaine will be injected using 2 syringes, so 10ml of 0.5% plain bupivacaine will be injected, and immediately followed by another 10ml of 0.5% plain bupivacaine. |
| To receive supraclavicular BPB using liposomal bupivacaine together with ropivacaine. | Experimental | Drug: Bupivacaine Liposome 13.3 MG/ML [Exparel]10ml of 0.5% plain bupivacaine will be injected, and immediately followed by 10ml of 1.33% liposomal bupivacaine. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologist (ASA) status I-III
- Age 18-90 years old
- Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)
- Patients with informed consent to participate in the study
Key exclusion criteria (25 listed)
- Ulnar shaft/ neck physis fracture
- Revision surgery
- Previous fractures or surgery in the affected distal radius
- Surgery involving more than the affected arm
- Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine Injection [Marcaine]Bupivacaine injection [Marcaine] is the standard treatment used in our hospital. | Drug | To receive supraclavicular BPB using standard ropivacaine only. |
| Bupivacaine Liposome 13.3 MG/ML [Exparel]Bupivacaine liposome is a multivesicular formulation of bupivacaine that allows rapid absorption and prolonged release of bupivacaine. | Drug | To receive supraclavicular BPB using liposomal bupivacaine together with ropivacaine. |
Primary outcome
postoperative AUC pain score at rest
Time frame: First 48 hours after surgery
Pain severity would be rated at rest after surgery using numerical rating scale with 0 to 10 where 0=no pain and 10=the worst possible pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Injection [Marcaine] and Bupivacaine Liposome 13.3 MG/ML [Exparel] in people with Acute Pain, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative AUC pain score at rest (time frame: First 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.